BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3061199 · Received April 16, 2013

    Report

    Report Number
    3008203003-2013-00047
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT REPAIR RECORD IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT IN AN A-FIB (ATRIAL FIBRILLATION) PROCEDURE, A MAP SHIFT OCCURRED AFTER THE PATIENT WAS CARDIOVERTED. THE REPORTER BELIEVED THAT THE PATIENT DID NOT MOVE. MAP SHIFTS AFTER CARDIOVERSION OCCURS BECAUSE THE PATIENT'S HEART CAN PHYSICALLY MOVE WITH RESPECT TO THE INITIAL PATCH REFERENCE POSITIONS. CARTO IS NOT INTENDED TO FIX SUCH RELATIVE MOTION. IFU STATES: "IN RARE CASES, THE RELATIVE POSITION BETWEEN THE PATCHES REMAINS THE SAME BUT THE POSITION OF THE HEART RELATIVE TO THE BACK PATCHES HAS CHANGED (FOR EXAMPLE, AFTER REPOSITIONING THE PATIENT'S HEAD ON A PILLOW OR MOVING THE PATIENT'S ARM WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS, OR AFTER THE PATIENT IS CARDIOVERTED). DUE TO SUCH INTERNAL ANATOMIC DISPLACEMENTS, THERE MIGHT BE MISALIGNMENT OF THE MAP TO THE HEART LOCATION", "THE SYSTEM WILL NOT GIVE A WARNING AND AN INCORRECT MAP (MAP SHIFT) MIGHT BE GENERATED". "WHEN IN DOUBT, CLOSE THE CURRENT MAP AND BEGIN A NEW ONE". FIELD SERVICING ENGINEER (FSE) PROVIDED CASE SUPPORT. THE FSE ADVISED TO THE CLINICAL SPECIALIST THAT THE PATCHES WERE NOT PLACED CORRECTLY ON THE PATIENT AND EXPLAINED THE CORRECT WAY OF PLACING THEM. CLINICAL SPECIALIST ADVISED THE ACCOUNT OF THIS SITUATION. AFTER THIS THE SYSTEM WAS FOUND OPERATIONAL. THE DHR ASSOCIATED WITH CARTO 3 #10278 WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN AN A-FIB (ATRIAL FIBRILLATION) PROCEDURE, A MAP SHIFT OCCURRED AFTER THE PATIENT WAS CARDIOVERTED. THE REPORTER BELIEVED THAT THE PATIENT DID NOT MOVE. THREE ATTEMPTS WERE PERFORMED TRYING TO OBTAIN DETAIL INFORMATION ABOUT THE EVENT WITH NO SUCCESS. DUE TO THE FACT THAT NO ADDITIONAL INFORMATION REGARDING MAP SHIFT WAS RECEIVED, IT WAS DECIDED TO REPORT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162457 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1